• Anika Therapeutics Inc., of Woburn, Mass., signed a multiyear supply agreement with Bausch & Lomb Inc., of Rochester, N.Y., for viscoelastic products used in ophthalmic surgery. Viscoelastic products, composed of hyaluronic acid, protect eye tissue and maintain eye structure during cataract and certain refractive surgeries.

• Applied DNA Sciences Inc., of Los Angeles, signed an agreement with the Department of Energy's laboratory in Idaho to develop the next generation of analytical tools used for DNA analysis. Scientists will work to improve DNA forensic-testing tools that build on polymerase chain reaction detection of DNA recovered from security-marked materials. Articles spiked with the DNA marker will help thwart counterfeiting, gray market corruption and enhance accounting of sensitive materials.

• Aradigm Corp., of Hayward, Calif., entered a definitive agreement for a $12.5 million private placement of common stock and warrants. Aradigm will sell about 8.3 million shares at $1.50 each, a 16 percent discount. Total net proceeds would be $11.75 million, which the company plans to use to advance its research and development efforts, as well as for working capital and general operations. SG Cowen is lead placement agent and Punk Ziegel is serving as co-agent for the transaction. Along with $50 million expected from Bagsvaerd, Denmark-based Novo Nordisk A/S as part of a restructured agreement for the AERx insulin diabetes management system, Aradigm said the added financing will help the company fund operations to 2007. (See BioWorld Today, Sept. 30, 2004.)

• Cangene Corp., of Toronto, completed the European mutual recognition procedure for the approval of WinRho SDF in 10 European countries for use in preventing hemolytic disease of the newborn and treating ITP, a clotting disorder. Launch is planned for next year. The antibody product was approved in the UK in 1999.

• Chiron Corp., of Emeryville, Calif., said the SEC declared effective its registration statement relating to the resale of $385 million worth of its 2.75 percent convertible debentures due 2034 and the shares of common stock issuable upon conversion of the notes. The debentures originally were issued in a private placement in June. Chiron will not receive proceeds from any resale by the selling security holders of the debentures or the shares of common stock.

• Commonwealth Biotechnologies Inc., of Richmond, Va., completed its acquisition of the assets of Fairfax Identity Labs, a division of Genetics & IVF Institute Inc., of Fairfax, Va. It became a division of Commonwealth, and the transfer of all its equipment and personnel is expected to be completed by the end of the year.

• The Dana-Farber Cancer Institute in Boston said it discovered that melanoma cannot grow without the protein CDK2. Although previous studies reported that other cancers were not affected by CDK2 inhibitors, the institute's findings, published in the December 2004 issue of Cancer Cell, suggest that inhibitors might curb the growth of skin cancer with low toxicity to patients.

• Debiopharm SA, of Lausanne, Switzerland, entered an exclusive licensing agreement with Rowfarma S de RL de CV, a subsidiary of Quintiles Transnational Corp., of Research Triangle Park, N.C., to market Decapeptyl Depot 3.75 mg and Decapeptyl LA 11.25 mg in Mexico. Debiopharm will supply Decapeptyl from its FDA-inspected plant in Switzerland exclusively to Rowfarma and will receive royalties on sales in Mexico. The product, an intramuscular injectable formulation of triptorelin pamoate, is registered there for prostate cancer, endometriosis, precocious puberty and breast cancer.

• Durect Corp., of Cupertino, Calif., and Voyager Pharmaceutical Corp., of Raleigh, N.C., said the FDA accepted an investigational new drug application for a Durin-based leuprolide acetate treatment for Alzheimer's disease. Voyager is enrolling healthy volunteers for the study, which will be conducted along with its two Phase II Alzheimer's studies. Results are expected in 2005.

• Dynavax Technologies Corp., of Berkeley, Calif., said a one-year interim analysis of its two-year Phase II/III trial of its ragweed allergy ISS-based therapeutic (AIC, or Amb a 1 ISS conjugate) showed a clear positive trend relative to the trial's major endpoint of nasal symptom scores, as well as other secondary endpoints, following this year's ragweed season. The analysis also indicated that AIC was safely administered and systemic adverse reactions were similar between the AIC and control arms. Dynavax intends to complete the 462-patient trial as planned; it will remain blinded until final data are collected and fully analyzed.

• EpiVax Inc., of Providence, R.I., was awarded a BioDefense Phase I Small Business Innovation Research grant by the National Institutes of Health's Institute of Allergy and Infectious Diseases for developing a genome-derived, epitope-driven smallpox vaccine. The $993,771 grant will be used to screen the genomes of smallpox and cowpox for epitopes that drive immunity, though researchers will not use the actual virus.

• Genaissance Pharmaceuticals Inc., of New Haven, Conn., identified genetic markers the company said might predict whether schizophrenics under treatment are at risk of developing clozapine-induced agranulocytosis. The company said findings from its CARING (Clozapine and Agranulocytosis Relationships Investigated by Genetics) study might apply to other drugs that affect white blood cell counts and require frequent blood testing.

• Genzyme Corp., of Cambridge, Mass., said the European Medicines Agency accepted its marketing authorization application for Myozyme (alglucosidase alfa), an investigational enzyme-replacement therapy for Pompe disease. The regulatory agency's Committee for Human Medicinal Products is expected to issue an opinion on the application within one year, and a decision by the European Commission is anticipated early in 2006. Myozyme has received orphan medicinal product designation in the European Union. Genzyme expects to submit a marketing application in the U.S. in the middle of next year, and applications in Japan and other countries will follow the U.S. submission.

• GTC Biotherapeutics Inc., of Framingham, Mass., submitted its response to the consolidated list of questions generated by the European Medicines Agency as part of the review of a marketing authorization application for ATryn, GTC's recombinant form of human anti-thrombin. The application covers the product's use in the prophylactic treatment of patients with hereditary anti-thrombin deficiency during high-risk situations such as surgery and childbirth. The company expects the EMEA to respond with additional questions or provide an opinion on the application by the end of April. Subject to approval, GTC is planning a European market launch in mid-2005. Separately, the company submitted an amendment to its investigational new drug application to begin a clinical study that may be used as a basis for FDA approval of ATryn for hereditary anti-thrombin deficiency. GTC expects to begin the study early next year.

• Guilford Pharmaceuticals Inc., of Baltimore, completed a sale and leaseback of its facilities in Baltimore with BioMed Realty Trust Inc., a real estate investment trust focused on acquiring, owning, leasing and developing a laboratory and office space for life science, biotechnology and pharmaceutical companies. The net proceeds to Guilford were $19.4 million. In connection with the transaction, Guilford has entered a long-term lease with BioMed for the facilities. Guilford intends to use the proceeds for general corporate purposes, including the continued advancement of its Aquavan Injection development program, now in Phase III studies.

• Hana Biosciences Inc., of South San Francisco, said results in the Journal of Clinical Cancer Research showed that experiments with human colon cancer xenograft models suggest that IPdR-mediated radiosensitization can be an effective in vivo approach to treat both drug-resistant mismatch repair deficient and proficient tumors. The FDA has placed a clinical hold on an investigational new drug application for IPdR (5-Iodo-2-pyrimidinone-2'-deoxyribose) to treat liver, pancreatic and colorectal cancers pending an additional toxicology study. Hana plans to assume sponsorship of the IND in the first quarter and to begin clinical studies later in the year.

• The Institute for Systems Biology in Seattle said research published in the Dec. 20, 2004, issue of The Journal of Cell Biology outlines two complementary experiments using isotope-coded affinity tags and tandem mass spectrometry to quantify the relative enrichment of proteins during the purification of peroxisomes. That allows scientists to distinguish those proteins that partition with peroxisomes from contaminating proteins and develop a catalog of candidate proteins that occupy the peroxisome in the yeast Saccharomyces cerevisiae.

• Inotek Pharmaceuticals Corp., of Beverly, Mass., began enrollment in a Phase II trial of its lead compound, INO-1001, to prevent cardiac necrosis in patients undergoing emergent angioplasty after acute myocardial infarction. The product inhibits the nuclear cell death enzyme poly (ADP-ribose) polymerase, or PARP. The study will include 40 patients, and its primary endpoint is safety and pharmacokinetics. Secondary endpoints are to evaluate markers of PARP activation and myocyte injury. Enrollment is expected to be complete in the second or third quarter, and a second Phase II in the same indication is expected to begin in the third or fourth quarter. That study will be in the same population and will evaluate myocardial infarct size as well as safety in more than 300 patients.

• IsoTis OrthoBiologics SA, of Lausanne, Switzerland, sold its wound-management activities to DFB Pharmaceuticals Inc., of Fort Worth, Texas, for an undisclosed amount. The parties entered a worldwide exclusive licensing agreement in August 2003 for Allox, a cell-based product to treat chronic skin wounds. IsoTis also established that year EpiSource SA, a potential spin-off company for its wound-management portfolio, which includes the lead product Allox, as well as EpiDex and AcuDress. With the transaction with DFB, IsoTis has divested all of its non-core activities and will focus solely on orthobiologics.

• Manhattan Pharmaceuticals Inc., of New York, received Swiss approval to begin human safety trials of Oleoyl estrone, the company's lead product candidate under development as an obesity therapeutic. The trials are designed to assess the naturally occurring molecule's safety and tolerability in obese volunteers.

• MethylGene Inc., of Montreal, initiated the first of two dose-escalating Phase I trials for MGCD0103 in hematological cancers. MGCD0103 is a rationally designed isotypic selective small-molecule inhibitor of histone deacetylase. The second hematologic cancer trial is scheduled to be initiated in early 2005. Both trials will evaluate the safety, pharmacokinetics, pharmacodynamics and tolerability of MGCD0103 in patients with leukemias or myelodysplastic syndrome.

• MorphoSys AG, of Martinsried, Germany, extended its collaboration with Schering AG, of Berlin, to develop antibody therapeutics and in vivo diagnostics. Originally signed in December 2001, the collaboration will be extended at least until the end of 2006, with the option of a further extension period of one year. MorphoSys receives annual license fees under the revised contract, funding for a team of scientists and royalties and milestone payments. Schering receives access to MorphoSys's HuCAL GOLD technology and exclusive commercial licenses for several collaborative programs.

• Neurogen Corp., of Branford, Conn., began Phase I human testing of its insomnia drug, NG2-73, which selectively modulates receptors of the gamma animobutyric neurotransmitter system. The company said preclinical studies suggest its drug might mark a reduction in next-day side effects associated with first-generation GABA hypnotic agents. Neurogen also is reviewing data from its Phase 1 study of NGD 96-3, also for insomnia, which began testing at Pfizer Inc., of New York, in March 2002.

• OSI Pharmaceuticals Inc., of Melville, N.Y., said it has been made aware of several class-action lawsuits filed against it, alleging that the company issued false and misleading statements concerning the survival benefit associated with Tarceva, and the size of its potential market upon FDA approval. OSI said it intends to defend itself vigorously.

• Point Therapeutics Inc., of Boston, filed a shelf registration statement with the SEC, which would permit the company to occasionally offer and sell up to $50 million of common stock and warrants. It plans to use proceeds from any offering for the continued clinical development of its lead product candidate, talabostat, in the treatment of a variety of cancers; preclinical research and development activities; potential acquisitions or in-licensing of new technologies; and for general corporate purposes.

• Praecis Pharmaceuticals Inc., of Waltham, Mass., said the Centers for Medicare and Medicaid Services (CMS) issued a draft decision memorandum in support of a national coverage determination for Plenaxis (abarelix). Consistent with the company's formal request, CMS proposed Medicare coverage for Plenaxis under the following conditions: The product must be administered to a patient meeting all criteria of the labeled indication, and the prescribing physician must be enrolled in the PLUS Program. When used in accordance with the product's label, there would be no limitation on coverage regardless of the duration of Plenaxis therapy.

• Predix Pharmaceuticals Inc., of Woburn, Mass., initiated Phase I trials of PRX-03140, which was discovered through computer-generated GPCR models and optimized with integrated computational-medicinal chemistry. The compound is a serotonin 4 (5-HT4) receptor agonist intended to treat Alzheimer's disease and other disorders of memory and cognition. The product has shown activity in several animal models of cognitive impairment, Predix said.

• RegeneRx Biopharmaceuticals Inc., of Bethesda, Md., filed with the FDA a request to initiate a Phase II trial to test Thymosin beta 4 (TB4) in treating venous stasis ulcers. The trial would be conducted in Europe by RegneRx's partner, Sigma-Tau Group, of Rome. It is designed to test several dosages of TB4, which would be topically administered. The trial should be completed and analyzed within 18 months. TB4 is a naturally occurring 43-amino-acid peptide present in human cells.

• Sanguine Corp., of Pasadena, Calif., said its budgets now are in place to plan FDA testing and to select a manufacturer of PHER-02 in early 2005. The company will convene a meeting in January of its medical advisory board to finalize the details. Additionally, Sanguine is in discussions with a company to manufacture PHER-02. The intent will be to manufacture PHER-02 for preclinical sales to universities and others in 2005. PHER-02 is a synthetic red blood cell product.

• Senomyx Inc., of La Jolla, Calif., submitted applications for review of its flavor enhancers, S336 and S807, to the Flavor and Extract Manufacturers Association for Generally Recognized as Safe determination under the provisions of the Food, Drug and Cosmetic Act. Senomyx is using taste receptor-based assays, screening technologies and optimization chemistry to discover and develop flavor enhancers and taste modulators for the packaged food and beverage industry.

• Serono Inc., of Rockland, Mass., received FDA approval for a Titration Pack for people who take Rebif (interferon beta-1a) to treat relapsing forms of multiple sclerosis. The company said the pack is designed to provide improved convenience and dosing accuracy for patients beginning Rebif therapy and will be available in the U.S. in early 2005. Rebif is a disease-modifying drug used to decrease MS relapses and delay the accumulation of physical disability.

• Solvay Pharmaceuticals Inc., of Marietta, Ga., said the FDA extended its review of the cilansetron new drug application from Jan. 1 to April 1. Cilansetron is expected to be discussed at a joint Gastrointestinal and Drug Safety and Risk Management Advisory Committee. Solvay is seeking approval to market cilansetron, an investigational 5-HT3 receptor antagonist, for irritable bowel syndrome with diarrhea predominance in men and women, and expects to launch the product in the U.S. shortly after approval expected next year.

• Tercica Inc., of South San Francisco, filed a suit for patent infringement in the UK against Insmed Inc., of Glen Allen, Va., and Avecia Ltd., of Billingham, UK. Tercica is seeking an injunction, damages and declaratory relief. The suit alleges that by making, using and selling SomatoKine to treat growth hormone insensitivity syndrome in the UK, the companies infringe a European patent under which Tercica holds an exclusive license. SomatoKine is a complex of insulin-like growth factor-1 and insulin-like growth factor binding protein-3.

• Threshold Pharmaceuticals Inc., of South San Francisco, initiated patient enrollment for a Phase I/II trial evaluating the dosing, safety and activity of Glufosfamide in combination with gemcitabine for treating advanced solid malignancies or as a first-line treatment for pancreatic cancer. The Phase I portion of the study may enroll up to 15 patients and will evaluate various doses of Glufosfamide in combination with the standard dose of gemcitabine in patients with any kind of advanced solid malignancy. The maximum tolerated dose will be used in the Phase II portion to treat patients with pancreatic cancer. That portion will enroll about 47 patients at various sites in the U.S. and Latin America.

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